Chrysalis Intelligence · Sponsors · bioMerieux, Inc.

bioMerieux, Inc.

Hazelwood, MO, US · 34 510(k) clearances · 3 PMAs · 129 recalls (1 Class I)

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Total clearances
34
2020-02-14 → 2026-07-08
Last 12 months
3
Product codes
6
Most recent
2026-07-08
Name variants in FDA filings: BIOMERIEUX / bioMerieux, Inc. / Biomerieux S.A.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Class II Microbiology 27 2026-04-15
JWY — — — 2 2025-04-30
NGZ Susceptibility Test Plate, Antifungal Class II Microbiology 2 2024-06-12
SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples Class II Microbiology 1 2026-07-08
QAT Brain Trauma Assessment Test Class II Immunology 1 2024-05-01
QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates Class II Microbiology 1 2022-03-15
Class III

PMA approvals (3)

Total PMA records
3
Originals + supplements
Distinct product codes
1
First decision
2020-02-26
Most recent
2021-12-20
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2021-12-20 P120014-S012 THXID™-BRAF 30-Day Notice OWD — —
2021-03-10 P120014-S011 THxID-BRAF kit 30-Day Notice OWD — —
2020-02-26 P120014-S010 THxID-BRAF assay kit 30-Day Notice OWD — —
Safety

Recalls (129)

Class I (serious)
1
Risk of injury / death
Total recalls
129
Currently ongoing
119
Most recent
2026-06-04
DateSeverityStatusRecall # ProductCodeReason
2026-06-04 Class II Ongoing Z-2715-2026 VITEK 2 AST-N447 TEST KIT Product reference 424620 — Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
2026-01-05 Class II Ongoing Z-1236-2026 VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem… — Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or…
2025-06-26 Class II Ongoing Z-2671-2025 VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system c… — Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific…
2024-03-14 Class I Ongoing Z-1464-2024 VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; … — Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible resu…
2023-02-06 Class II Ongoing Z-1201-2023 MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments … — For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always be…
2022-11-09 Class II Ongoing Z-0876-2023 PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0875-2023 PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0874-2023 PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0873-2023 PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0872-2023 PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0871-2023 PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0870-2023 PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0869-2023 DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0868-2023 VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0867-2023 VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0866-2023 VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0865-2023 VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0864-2023 VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0863-2023 ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0862-2023 ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0861-2023 VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0860-2023 ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0859-2023 ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0858-2023 PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0857-2023 VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0856-2023 VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0855-2023 GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0854-2023 VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0853-2023 VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0852-2023 ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0851-2023 ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0850-2023 VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0849-2023 ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0848-2023 VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0847-2023 PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0846-2023 ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0845-2023 PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0844-2023 PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0843-2023 VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0842-2023 PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0841-2023 ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0840-2023 GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0839-2023 PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0838-2023 VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0837-2023 VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0836-2023 VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0835-2023 VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0834-2023 VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0833-2023 VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0832-2023 BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0831-2023 ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0830-2023 ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0829-2023 ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0828-2023 ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0827-2023 ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0826-2023 ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0825-2023 ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0824-2023 ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0823-2023 ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0822-2023 ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0821-2023 ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0820-2023 ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0819-2023 ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0818-2023 ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0817-2023 ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0816-2023 VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0815-2023 VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0814-2023 VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0813-2023 PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0812-2023 ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0811-2023 TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0810-2023 API JAMES 2AMP, CATALOG 70542 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0809-2023 API NIT1 NIT2 REAGENTS, CATALOG 70442 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0808-2023 API VP1 VP2 REAGENTS, CATALOG 70422 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0807-2023 BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0806-2023 BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0805-2023 BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0804-2023 PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0803-2023 PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0802-2023 PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0801-2023 PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0800-2023 VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0799-2023 VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0798-2023 VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0797-2023 VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0796-2023 VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0795-2023 VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0794-2023 PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0793-2023 PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0792-2023 VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0791-2023 VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0790-2023 VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0789-2023 VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0788-2023 VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0787-2023 VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0786-2023 API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0785-2023 API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0784-2023 API 20 E 25 STRIPS, CATALOG 20100 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09 Class II Ongoing Z-0783-2023 API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300 — As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-07-20 Class II Ongoing Z-1564-2022 NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit. — There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
2022-07-13 Class II Ongoing Z-1640-2022 VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V… — There are 7 reported software anomalies that may affect use of the device.
2022-03-29 Class II Ongoing Z-1059-2022 VITEK 2 Systems and VITEK 2 with MYLA. — Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected int…
2022-02-09 Class II Terminated Z-0742-2022 VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. — Invalid calibrations (out of range high) while using the product.
2021-12-20 Class II Terminated Z-0525-2022 API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identifica… — Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
2021-11-09 Class II Terminated Z-0422-2022 RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD. — There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
2021-09-30 Class II Terminated Z-0243-2022 API 50 CH, Model 50300 — There is potential to provide an incorrect organism identification.
2021-09-22 Class II Ongoing Z-0439-2022 VIDAS SARS-COV-2 IgG, Ref 423834-01 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0438-2022 VIDAS SARS-COV-2 IgM, Ref 423833-01 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0437-2022 VIDAS Lyme IgG II (LYM), REF 417401 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0436-2022 VIDAS Lyme IgM II (LYM), REF 416436 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0435-2022 VIDAS Estradiol II, REF 30431-01 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0434-2022 VIDAS FSH, REF 30407-01 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0433-2022 VIDAS LH, REF 30406-01 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0432-2022 VIDAS RUB IgG (RBG), REF 30226 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0431-2022 VIDAS TOXO IgG Avidity (TXGA), REF 30222-01 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0430-2022 VIDAS Measles IgG (MSG), REF 30219 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0429-2022 VIDAS Mumps IgG (MPG), REF 30218 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0428-2022 VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0427-2022 VIDAS DEX@, Dimer Exclusion II, REF 30455-01 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0426-2022 VIDAS Clostridium Difficile GDH, REF 30125-01 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0425-2022 VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-09-22 Class II Ongoing Z-0424-2022 VIDAS PRG Progesterone, REF 30409-01 — bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote…
2021-06-24 Class II Terminated Z-2226-2021 ETEST IMIPENEM RELEBACTAM. in vitro diagnostic — Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
2021-03-16 Class II Terminated Z-1408-2021 VIDAS¿ CMV IgM 30 Tests — bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).
2021-01-28 Class II Terminated Z-1308-2021 VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to H… — bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Co…
2021-01-28 Class II Terminated Z-1307-2021 VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (syst… — bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Co…
2020-03-11 Class II Ongoing Z-1742-2020 The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as a… — There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card…
2020-02-05 Class II Terminated Z-1534-2020 VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reage… — The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
2020-01-24 Class II Terminated Z-1793-2020 PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 … — The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP2824 Plus printer PSU (power supply unit) located w…
Filings

All 510(k) clearances (34)

Date K-number Device Code Class Specialty
2026-07-08 K260160 VITEK REVEAL GN AST Assay and VITEK REVEAL AST System SAN Class II Microbiology
2026-04-15 K260282 VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance LON Class II Microbiology
2026-03-26 K260281 VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) LON Class II Microbiology
2025-08-21 K251579 VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) LON Class II Microbiology
2025-04-30 K250274 ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) JWY — —
2025-03-14 K234012 VITEK COMPACT PRO LON Class II Microbiology
2024-06-12 K232967 VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) NGZ Class II Microbiology
2024-06-07 K232963 VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) NGZ Class II Microbiology
2024-05-01 K240279 VIDAS TBI (GFAP, UCH-L1) QAT Class II Immunology
2024-03-11 K234000 VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) LON Class II Microbiology
2023-10-23 K232201 VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin LON Class II Microbiology
2023-07-05 K230864 VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin LON Class II Microbiology
2023-06-26 K222378 VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL) LON Class II Microbiology
2023-02-16 K223478 VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin LON Class II Microbiology
2023-02-09 K222073 VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) LON Class II Microbiology
2023-02-03 K223481 VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) LON Class II Microbiology
2023-01-27 K220803 VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin LON Class II Microbiology
2022-10-13 K220805 VITEK 2 AST-Gram Positive Cefoxitin Screen LON Class II Microbiology
2022-08-08 K212243 VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) LON Class II Microbiology
2022-07-12 K213899 VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin LON Class II Microbiology
2022-06-03 K213931 VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) LON Class II Microbiology
2022-04-14 K214023 VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) LON Class II Microbiology
2022-03-15 K212461 VITEK MS PRIME QBN Class II Microbiology
2022-02-25 K213241 VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole LON Class II Microbiology
2021-11-12 K210757 ETEST Fosfomycin (FO) (0.032-512 µg/mL) JWY — —
2021-10-28 K210287 VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) LON Class II Microbiology
2021-09-14 K202396 VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) LON Class II Microbiology
2021-08-30 K211630 VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) LON Class II Microbiology
2021-07-09 K201675 VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) LON Class II Microbiology
2021-06-14 K211136 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) LON Class II Microbiology
2020-09-28 K193299 VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) LON Class II Microbiology
2020-04-28 K200590 VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) LON Class II Microbiology
2020-03-13 K193572 VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) LON Class II Microbiology
2020-02-14 K193567 VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL) LON Class II Microbiology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence